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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring.

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Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

Pharmacy Times

The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616).

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FDA Removes REMS for Currently Approved BCMA-, CD19-Directed CAR T Cell Immunotherapies

Pharmacy Times

REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. Increased experience in managing CAR T therapy toxicities has led to the removal of REMS, facilitating broader access.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.

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Large Real-World Study Validates Idecabtagene Vicleucel Outcomes Seen in KarMMa Trial

Pharmacy Times

Immune effector cell–associated neurotoxicity syndrome was less common but observed in 28% (grade ≥3, 5%). 2025029274 Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Doi:10.1182/blood.2025029274 Subscribe Now!

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Pharmacists Have a Crucial Role Helping Patients With ATTR-CM Navigate Treatment With Tafamidis

Pharmacy Times

Additionally, tafamidis stands out compared with other TTR stabilizers that are used off-label and require monitoring for renal and gastrointestinal AEs. In addition to efficacy and safety, the investigators aim to provide valuable information on functional capacity and survival in this open-label extension.